BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFE PAK

    MDR report key: 35330 · Received July 8, 1996

    Report

    Report Number
    35330
    Event Type
    Malfunction
    Date Received
    July 8, 1996
    Date of Event
    January 3, 1996
    Report Date
    January 4, 1996
    Manufacturer
    PHYSIO CONTROL
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS HAVING CARDIOVERSION. PADS WERE IN PLACE. MACHINE WAS SET FOR 360 AND IT FAILED TO DISCHARGE. CHARGE AGAIN BUT AGAIN, FAILED TO DISCHARGE. CHARGED AGAIN BUT AGAIN, FAILED TO DISCHARGE. TSS CAME INTO DEPARTMENT FOR ANOTHER REASON ASKED TO CHECK MACHINE. NURSE WENT TO CATH LAB AND OBTAINED ANOTHER DEFIBRLLATOR. TSS CUT THE POWER OFF, WAITED 10 SEC., THEN TURNED BACK ON. MACHINE FUNCTIONED PROPERLY. FOLLOWING CARDIOVERSION, STAFF MEMBER NOTICED PACER LIGHT WAS ON AND STARTED PACING AT 60. (THIS WAS DONE WITHOUT BEING TOLD TO DO SO BY THE STAFF-STAFF WAS NOT NEAR THE EQUIPMENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFE PAK DEFIBRILLATOR-LIFEPAK LDD PHYSIO CONTROL 9-P NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR